Heroin Assisted Treatment in Andalusia: The PEPSA Trial

ISRCTN	ISRCTN52023186
DOI	https://doi.org/10.1186/ISRCTN52023186
EudraCT/CTIS number	2005-002896-33
Secondary identifying numbers	N/A

Submission date: 03/08/2008
Registration date: 19/02/2009
Last edited: 16/11/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr Eugenia Oviedo-Joekes
Scientific

School of Population and Public Health
University of British Columbia
Centre for Health Evaluation & Outcome Sciences
St. Paul's Hospital
620-1081 Burrard Street
Vancouver, BC
V6Z 1Y6
Canada

Phone	+1 604 682 2344 Ext 62973
Email	eugenia@mail.cheos.ubc.ca

Study information

Study design	Open randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Scientific title	Efficacy of prescribed injected diacetylmorphine in the Andalusian trial: responders and non-responders evaluated using a multi-domain outcome index
Study acronym	PEPSA
Study objectives	The impact of intravenous diacetylmorphine (DAM) plus oral methadone is better than a treatment with oral methadone alone on the physical and mental health and social integration of refractory opioid addicts.
Ethics approval(s)	Ethics board of the Hospital Virgen de las Nieves, approved on 01/08/2001 (ref: 01/15.2)
Health condition(s) or problem(s) studied	Refractory opioid addicts
Intervention	Participants in the experimental group received DAM (heroin) injection twice a day, plus oral methadone once a day (to be taken at home) for 9 months. The control group received only oral methadone to be taken once a day. Dosage: The two groups received an equivalent opioid dose. Among treatment completers, an average DAM dosage of 274.5 mg/day (range: 15-600 mg) and an average methadone dosage of 42.6 mg/day (range 18-124 mg) were prescribed for the experimental group. The daily methadone dosage in the control group was 105 mg/day (range: 40-180 mg). As a result, the approximate mean daily total equivalent dosage of DAM/day for the experimental group was between 395.5 and 414.5 mg/day; for the control group, it was between 361 and 400 mg/day. Of the 62 participants, 44 completed the treatment and 50 patients were analysed. Contact details of Principal Investigator: Dr Joan Carles March Andalusian School of Public Health (EASP) Granada 18014, Spain Tel: +34 958 027 400 Email: emilio.pereamilla@gmail.com
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Diacetylmorphine (DAM; heroin), methadone
Primary outcome measure	A dichotomous multidimension outcome (MDO) index was determined by protocol as a primary outcome variable, imputing success when the patient showed at least 20% improvement at 9 months, compared with the baseline values, in general health or psychological or family adjustment, without a deterioration superior to 20% in any of these dimensions evaluated with the respective Addiction Severity Index (ASI) composite scores.
Secondary outcome measures	The following were assessed before randomisation, at 3, 6 and 9 months (end of the trial): 1. Physical and mental health, assessed by the Opiate Treatment Index (OTI), Symptom Checklist (SCL) and Maudsley Addiction Profile (MAP) 2. Psychosocial adjustment, assessed by the OTI and ASI 3. Treatment retention 4. Illegal activities, assessed by the ASI 5. Illicit drug use, assessed by the OTI and ASI 6. Quality of life, assessed by the Health Related Quality of Life 12-item Short Form (SF-12)
Overall study start date	15/02/2003
Completion date	15/12/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	62
Key inclusion criteria	1. Both males and females, 21 years or older 2. Long-term opioid-dependent persons who had not been benefited from other treatments Potential participants were interviewed in squares, soup kitchens and methadone dispensaries by outreach workers and peers, who suggested they make an appointment with a PEPSA physician.
Key exclusion criteria	1. Non-agreement to participate 2. Psycho-social impairment to answer the questionnaires 3. Current medical, social or legal situation that is likely to result in an discontinuation period longer than the study period (9 months)
Date of first enrolment	15/02/2003
Date of final enrolment	15/12/2004

Locations

Countries of recruitment

Canada
Spain

Study participating centre

School of Population and Public Health

Vancouver, BC
V6Z 1Y6
Canada

Sponsor information

Drug Commission, Council for Equality and Social Welfare (Spain)
Government

C/o Andrés Estrada Moreno
Director General para las Drogodependencias y Adicciones
Consejería para la Igualdad y Bienestar Social
Junta de Andalucia
Avenida de Hytasa, 14
Sevilla
41071
Spain

Phone	+34 955 048 000
Email	DGDrogodependenciasyAdicciones.cibs@juntadeandalucia.es

Funders

Funder type

Government

Committee on Drug Dependence, Carlos III Health Institute (Spain)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Protocol article	protocol	01/05/2004	Yes	No
Results article	main results:	01/09/2006	Yes	No
Other publications	review including data from this trial	01/07/2007	Yes	No
Results article	results	01/07/2008	Yes	No
Results article	results, comparing the baseline data from Canadian sample with the European trials, including the data from this trial:	01/11/2008	Yes	No
Results article	results	14/08/2009	Yes	No